Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

A: Intervention Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Impact® Advanced Recovery: Three times daily for the 5 days just prior to the start of each cycle of chemotherapy. Participants will undergo pre- and post-treatment assessments.

B: Control Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Boost® High Protein: Identical schedule of a supplement with similar calorie and protein content, Boost® High Protein. Participants will undergo pre- and post-treatment assessments.

The intervention drink Impact® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.

Impact® Advanced Recovery

The control supplement drink Boost® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.

Boost® High Protein

Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.

Radiation Therapy

Standard of Care: Chemotherapy as already planned for each participant.

Chemotherapy

Participants will undergo pre- and post-treatment assessments.

Quality of life (EORTC-QLQ-30)

Evaluation of Cognitive Function (FACT-Cog, v. 3.0)

Mindfulness Questionnaire (FFMQ)

Lary A. Robinson, M.D.

The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer.

Randomized open-label, medical and radiation oncologist-blinded.

Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

The Use of Immunonutrition to Reduce Toxicities From Concurrent Chemotherapy and Radiotherapy for Treatment of Unresectable Stage IIIA-B Non-Small Cell Lung Cancer (NSCLC)

Overall toxicity from therapy as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0 that directly correlates with toxicity from concurrent chemoradiotherapy. Based on another randomized trial using pretreatment immunonutrition, investigators want to see if this nutritional intervention will likely decrease overall chemoradiotherapy related toxicity. All toxicity and adverse events (CTCAE v.5.0) will be assessed weekly and attributed by the treating radiation oncologist and entered into the clinical trials management database OnCore for later statistical analysis. Differences in toxicity events at the end of the study in participants receiving Impact® and those receiving Boost® will be compared using two-sample t-test.

Measurement of the marked change of IL-6 that directly correlates with toxicity from concurrent chemoradiotherapy. Multiplex immunoassay will be used to determine the plasma levels of IL-6 in pg/ml as a continuous variable. Two-sample t-test for change in IL-6 at the last visit from the baseline will be compared between the two arms. Kolmogorove-Smirnov and Jarque-Bera tests will be performed to test for normality assumption on the primary endpoints prior to t-test analysis. If either test indicates a violation of the normality assumption, investigators will use an appropriate rank-based Wilcoxon rank-sum test instead of t-test.

Overall survival (OS) defined as the length of time interval between the date of cancer treatment completion and the date of death due to any cause. Kaplan-Meier curves will be estimated for each arm. Log-rank test will be performed to examine the effect of Impact® vs. Boost® on measures of OS.

Progression-free survival (PFS) will be assessed using the length of time interval from the cancer treatment completion to the earlier of the first documentation of disease progression or death from any cause. Kaplan-Meier curves will be estimated for each arm. Log-rank test will be performed to examine the effect of Impact® vs. Boost® on measures of PFS.

Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.

Rate of participant compliance, with immunonutrition regimen, according to participant diaries. Each participant will complete a compliance diary noting when each carton/bottle of the study agent is drunk and the card will be collected by the Study Coordinator at on treatment clinic visits (OTV) prior to receiving the new batch of study or control supplements.

Nestle Health Science

H. Lee Moffitt Cancer Center and Research Institute

Establish predictive markers for early disease progression after complete surgical resection in patients with stage I to IIIA NSCLC.

Additional blood sampling

Michiel Thomeer, prof. dr.

Elien Derveaux, drs.

Liesbet Mesotten, prof. dr.

peter Adriaensens, prof. dr.

Complete resection is the mainstay of treatment for stage I-IIIA resectable non-small cell lung cancer (NSCLC). However rates of recurrence of disease are high, with five-year survival rates ranging between 73% (stage IA) and 24% (stage IIIA). Therefore, a prognostic biological marker that stratifies between NSCLC patients whom surgery cures versus patients in whom surgery would be futile due to early disease relapse after surgery is eagerly awaited.

The primary objective of this prospective study is to establish a prognostic marker of early disease progression after complete surgical resection in patients with stages I to IIIA NSCLC. For this purpose the investigator will compare the metabolic profile with disease progression or death within one year after complete surgical resection to the patients with a progression free survival. Furthermore the investigator will evaluate the changes in the metabolic profile after surgery and if changes in this metabolic profile over time can predict disease recurrence before it becomes clinically apparent.

Introduction: Precision medicine relies on validated biomarkers that can accurately classify patients by their probable disease risk, prognosis and/or response to treatment. Metabolomics is particularly promising for biomarker development because altered metabolism is considered a hallmark of cancer. The measurement of the metabolomic plasma profile is cheap (+-50 EUR) and fast (+-17 min), with a high information throughput on a per sample base.

Rationale: Complete resection is the mainstay of treatment for stage I-IIIA resectable non-small cell lung cancer (NSCLC). However rates of recurrence of disease are high, with five-year survival rates ranging between 73% (stage IA) and 24% (stage IIIA). Therefore, a prognostic biological marker that stratifies between NSCLC patients whom surgery cures versus patients in whom surgery would be futile due to early disease relapse after surgery is eagerly awaited.

Study objective: The primary study hypothesis is that the metabolic plasma profile is a predictive marker of early disease progression after complete surgical resection in patients with pathological stages I to IIIA NSCLC. The secondary study hypothesis is that the level of dissimilarity between the metabolic profile before surgery and the metabolic profile after surgery, is a predictor for disease recurrence (in which the extreme case would be, that a normalization of the metabolic profile to the profile of a healthy person, is indicative of a good prognosis).

Study design: Prospective, interventional design

Study population: Stage I-IIIA NSCLC patients who will undergo complete surgical resection willing to provide a written informed consent.

Number of patients: 200 patients with stage I-IIIA NSCLC who will undergo thoracic surgery with a curative intent will be included.

Main study parameters/endpoints: Recurrence free survival, overall survival, metabolic phenotype, presence or absence of hot-spot mutations in tested proto-oncogenes and tumor suppressor genes in circulating tumor DNA (ctDNA) in blood plasma, the tumor tissue and possibly positive lymph nodes, 43 items of the EORTC quality of life questionnaire C30 and LC13.

Nature and extent of the burden and risks associated with participation: Subjects will be asked to give consent to take 10-30 ml of blood at several moments throughout the disease course and in follow-up. Furthermore, the participants need to give their permission to use the resected tumor/lymph node tissue for genetic testing. Clinical parameters will be pooled in a database in a confidential way.

Metabolomics Predict Therapy Response

Towards Better Therapy for Resectable Lung Cancer: Metabolomics Predict Therapy Response

still no plan for, but open for sharing after discussion with participating groups

The metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR) spectroscopy predicts disease disease recurrence within one year after surgical resection.

The degree of change in the metabolic profile in plasma before and after surgery correlates with the risk for early disease recurrence.

The degree of change in ctDNA mutations in plasma before and after surgery correlates with the risk for early disease recurrence.

A specific metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR) spectroscopy correlates with the presence of absence of certain ctDNA mutations in plasma

The metabolic profile of the primary tumor correlates with the metabolic profile in plasma

Ziekenhuis Oost-Limburg

Hasselt University

Head of department of respiratory medicine

Neoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery

Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery

Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP

PD-1 and chemotherapy

Jiang Fan, MD

Dong Lin, MD

This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.

The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD

This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).

The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.

A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations

Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer	NCT03628144	Non Small Cell ... NSCLC Non-small Cell ... Non-small Cell ... Non-small Cell ... NSCLC Stage III... NSCLC, Stage II...	Impact® Advance... Boost® High Pro... Radiation Thera... Chemotherapy Quality of life... Evaluation of C... Mindfulness Que...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer	NCT03628144	Non Small Cell ... NSCLC Non-small Cell ... Non-small Cell ... Non-small Cell ... NSCLC Stage III... NSCLC, Stage II...	Impact® Advance... Boost® High Pro... Radiation Thera... Chemotherapy Quality of life... Evaluation of C... Mindfulness Que...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Metabolomics Predict Therapy Response	NCT03736993	NSCLC, Stage II...	Additional bloo...	18 Years -	Hasselt University
Metabolomics Predict Therapy Response	NCT03736993	NSCLC, Stage II...	Additional bloo...	18 Years -	Hasselt University
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer	NCT03628144	Non Small Cell ... NSCLC Non-small Cell ... Non-small Cell ... Non-small Cell ... NSCLC Stage III... NSCLC, Stage II...	Impact® Advance... Boost® High Pro... Radiation Thera... Chemotherapy Quality of life... Evaluation of C... Mindfulness Que...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations	NCT05157776	NSCLC, Stage II... EGF-R Negative ... ALK Negative NS...	PD-1 and chemot...	18 Years - 75 Years	Tongji University

Spots Global Cancer Trial Database for nsclc, stage iiia